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EC number: 695-988-9 | CAS number: 100556-82-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Taking data from skin and eye irritation/corrosion and the inhalative sensitisation studies into account, it can be concluded that the test substance is non-irritating.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 10. Nov. to 13. Nov 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; the tested substance is a precursor or Reactive Black 5 Bis-Vinyl and hydrolyses in aqueous solution from the bis-ester to the bis-vinyl form
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.1 - 2.4 kg
- Housing: single
- Diet (ad libitum): Altromin 2123
- Water (ad libitum): deionized chlorated water from automated supply
- Acclimation period: NA
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 10. Nov To: 13. Nov. 1987 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm²
- Type of wrap if used: semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 4 hours
EVALUATION TIME
30-60 minutes, 24, 48, 72 hours after removal of bandage
SCORING SYSTEM: according to test guideline - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 30 to 60 min, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 30 to 60 min, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- no signs of irritation observed
- Other effects:
- light blue staining of test site
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- not irritating
no labelling necessary - Executive summary:
Testing of Remazol Schwarz B 50 flüssig for skin irritation in rabbots according to OECD TG 404 did not lead to any signs of dermal irritation. The test item has not to be classified as skin irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 17 to 20 March 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without GLP; the tested substance is a precursor or Reactive Black 5 Bis-Vinyl and hydrolyses in aqueous solution from the bis-ester to the bis-vinyl form
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No 187
- Principles of method if other than guideline:
- Federal Register 38, No 187
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 1.6 to 2.1 kg
- Housing: single
- Diet (e.g. ad libitum): Standard food ERKA 8300
- Water (e.g. ad libitum): tap water
- Acclimation period: NA
IN-LIFE DATES: From: 17. March To: 20. March 1980 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg pasted with 1 drop physiological saline solution
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The test item was applied to the left eye of each rabbit. The contra-lateral eye surved as intra-individual control. Evaluation 1, 7, 24, 48, and 72 hours after test item application by means of a magnifying lens. After 24 hours the eyes were rinsed with physiological saline solution. At 48 and 72 hours evaluation, fluorescein staining was used to verify the absence of corneal lesions.
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 7 hours
- Score:
- 11
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 10
- Max. score:
- 110
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 5
- Max. score:
- 110
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 2
- Max. score:
- 110
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 1
- Max. score:
- 110
- Other effects:
- no effects
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification according to EC: not irritating
slightly irritating according to Federal Register 38, No 187
Reference
Classification Index
0-10 non irritating
11-25 slightly irritating
26-56 moderately irritating
57-110 severely irritating
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation:
A GLP compliant acute dermal skin irritation/corrosion study in rabbits was performed with Reactive Black 5 in its bis-ester form according to OECD guideline 404. 3 rabbits were treated on shaved skin with the test substance for 4 h and observation up to 72 h. No signs of irritation observed other than light blue staining of test site. The mean oedema and erythema score noted was 0.
A study similar to OECD guideline 404 performed with 6 rabbits, over all mean irritation score noted was 3 wherein the reactions were not fully reversible within 72 h. Primary irritation index score was 2.96. According to the results of this study the test substance is slightly irritating according to Federal Register 38, No 187. No labelling required according to EU guideline. It can be noted that abrasion on skin causes epidermal injury and further expected to cause the skin irritation and adverse effects to epidermis. This reaction could be referred to the damage caused due to abrasion rather than due to the test substance application. In general abrasion is an elevated testing condition and results normally do not have to be taken into account for hazard assessment. Hence, can be concluded as not irritating to rabbit skin.
In a Barail-Test intracutaneous injection of 0.02 ml of an aqueous solution with 0.01 %, 0.1 %, 1 %, 10 % Reactive Black 5 concentration or physiological saline (control) were given to 3 rabbits. In addition, cutaneous administration of 0.5 ml of the 10 % preparation was applied to depilated flank skin of another 3 animals. The animals were observed up to 4 days. No irritation and other effects were observed. The overall mean irritation score was noted to be 0. Hence, test substance is determined as not irritating to rabbit skin.
Two other studies performed in the 1960ies and 1970ies reported the test substance as not irritating to rabbit skin.
Taking into consideration the results from the key study and other supporting studies, the test substance can be considered to be not irritating to rabbit skin.
Eye Irritation:
Two acute eye irritation/corrosion studies were performed following procedure mentioned in Federal Register 38, No.178. Six rabbits were treated with the test substance for 24 h and observation up to 72 h. Maximum mean total score (MMTS) after 72 h was observed to be 0 and 1 on a scale of 110 respectively. Based on the score, the test substance is determined to be not irritation to eye.
Taking the results from the above mentioned studies into consideration, the test substance can be determined to be not irritating to rabbit eye.
Respiratory irritation: No irritating effect was seen in the inhalative sensitization study in rats
Justification for classification or non-classification
Based on the finding in the skin and eye irritation studies, the test substance does not need to be classified according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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